Contribution of PMS Study toward Safer Drugs: The Indian Perspectives

Swiss physician and alchemist, Paracelsus, almost 600 years ago, quoted "All substances are poisons; there is none which is not poison. The right dose differentiates a poison and a remedy". The relevance of this statement is more significant than ever before. The potential of newly developed drugs to cause harm is universal. In addition most of the modern drugs are potent and pose an enormous risk of deleterious effects. Although known to everyone albeit we always use the infamous thalidomide tragedy of 1961 as a prime example of identifying the importance of drug safety worldwide. Every drug, no matter how trivial its therapeutic actions, has risks. The problem of adverse drug reactions as significant cause of a morbidity and mortality has been demonstrated by a number of studies during last decades. Every year millions of patients in developed nations are hospitalized and die from complications relating to adverse reactions from drugs. Over the years several studies have pointed out severe harmful effects of drugs as a result of which those drugs were withdrawn gradually from market. Of the 583 new active substances approved between 1972 and 1994, 59 were withdrawn later. There were 121 safety related withdrawals world wide between 1960 and 1999. During 1990 to 2001 in UK 24 drugs were withdrawn due to safety reasons. (Source: Fung et at. Drug information journal, 2001, vol. 35, pp 293-317)

DRUGS RECENTLY WITHDRAWN AND THEIR LATENT PERIOD OF TOXICITY

Source: Safety of medicines: A guide to detecting and reporting ADRs, WHO, Geneva 2002

There is very limited information available on ADRs in India. Unlike in developed nations the reporting of ADRs is not mandatory in India and therefore many undesirable effects of drugs are unreported. What is more alarming is the non-approved use of drug products. However new drugs, developed in elsewhere, are being regularly introduced in Indian market. Forty-five new drugs were approved and marketed in India between January 2003 and December 2003. It is undeniable fact that pharmaceutical industries pay less or no attention about assessment of potential contribution to existing therapies while introducing new drugs. In a 1991 report of 348 new drugs from US companies between 1981 and 1988 (Journal of American Medical Association, vol. 265, pp 420-2), US FDA found, 84% new drugs offered little or no therapeutic improvement over existing drugs and only 3% made an important potential contribution. In absence of well recognized adverse drug reactions reporting programme in India pharmaceutical manufacturers can play an active role in the collection, processing and evaluation of spontaneous adverse reaction reports as a part of post marketing surveillance study. Industries can create their own competence by knowledgeable staff in identified centres in dealing with this kind of data by utilizing a definite percentage of budgets earmarked for drug promotional expenses. Personnel responsible must be able to analyze all information in a benefit/risk context and pass drug safety information to the concerned authority and to the people. The surveillance study can further be expanded to include research institutes/universities in strengthening collection and analysis of various data. In this way it is possible to establish a drug marketing database for describing and estimating use of many new drug drugs with emphasis on recording serious side/adverse effects. Various patient demographics can also be included in this database. Any pharmaceutical industry operates within the coherent of society. Because drugs control the life and death of an individual, the pharmaceutical industry has social obligation in providing newly developed drugs that are safe with maximum possible required credential. Post marketing surveillance, although cannot unveil the full spectrum of ADRs, but will be a beginning of creating database for detection in local, regional and national levels. Good and safe drugs alleviate human sufferings and enhance the productive lives of the population, while questionable (new) ones do the opposite. And the precautionary approach the manufacturers take on their own produce, working closely after marketing, the more likely it is that not only drug treatment will make population hale and hearty but also enhances industries' image in society. The World Health Organization (WHO) in its recent report on Disability Adjusted Life Expectancy, abbreviated as DALE has placed India 134 rank having DALE of 53.2, well below strife torn Fiji, Indonesia and Bosnia-Herzegovina and even neighboring island country Maldives. With improved sanitation and public health along with safer drug (as a result of post marketing surveillance) people may expect a healthier life in the days to come. The author is Selection Grade Lecturer in Pharmacy, Annamalai University, Annmalainagar, TN